Ensures quality data collection, processing, and review within study scope and aligned with department SOPs. This includes the creation, management, and execution of data plans, specifications, guidelines, listings, and reports.• Interacts with internal and external project team members (including external data source vendors) for multiple projects. Actively contributes to study team discussions, standing meeting agendas, meeting attendance and review of minutes.• Facilitate clinical database development to properly execute collection, reporting, review and archiving of quality clinical trial data. Includes eCRF planning discussions, coordination of eCRF review, planning and identification of system and protocol specific edit checks, coordination and proper execution of User Acceptance Testing, and coordination, planning and development for external data sources as needed.• Communicates with assigned data team members to ensure tasks are coordinated and executed as per study plans and timelines. Ensures training of study specific protocol requirements as appropriate.• Therapeutic areas include Pediatric Rare Disease (Phelan-McDermid Syndrome/Pitt Hopkins Syndrome), Oncology (Advanced Cancers), Bronchopulmonary Dysplasia in preterm neonates• Served as a Subject Matter Expert on the Medrio EDC system.• Received praise from Executive Director for skillful handling of difficult clients.

Responsible for planning and executing the clinical data management processes related to clinical studies performed at the clinical organization. This includes designing, testing, conducting and archiving all activities related to clinical study data both with internal study teams and external study teams and associated vendors.• Develop, implement, and maintain documentation including: Data Management Plan, User Acceptance Testing Plans, and CRF Completion Guidelines.• Guide development of CRFs and edit checks, then lead the UAT process, incorporating feedback from sponsors• Manage timelines related to clinical data management activities• Review, code, query, clean and archive clinical study data• Provide study and data metrics to study team, identifying any data issues • Participate in study team meetings and provide support for technology solutions• Therapeutic areas include Atopic Dermatitis, baby formula, NICU/PICU Fatty Acid Deficiency, COVID testing• Locked 4 databases in a one month span, all on schedule

Focused on study start-up for oncology trials including creating and testing edit checks and database UAT. Other primary responsibility is an ongoing oncology trial where I am responsible for creation and distribution of study metrics, running, distributing, and reviewing listings, and the development of some vendor listings.• Study metrics include use of pivot tables and extensive use of formulas to provide top line data• Frequent usage of VLOOKUP command in excel while reviewing listings• Document creation and contributions have included eCRF Completion Guidelines and Edit Check Specifications

Assigned as a co-lead on a Phase II Lymphoma study. Ran listings reports and assigned reviewresponsibilities. Reviewed and reconciled vendor listings. Opened and resolved sponsor requestedqueries. Created listing specifications for a lab vendor listing.

■ Transitioned from position as a Senior CRA to assist in build-up of Data Management department.■ Reviewed clinical trial data in accordance with Data Management Plans and applicable SOPs to identify erroneous, missing, incomplete, or implausible data.■ Generated, resolved, and tracked queries that were issued as a result of the problematic data identified during data review activities.■ Completed reconciliation of third party vendor data (central laboratory, ECG readings, photography database).■ Reviewed CRF, edit checks, and completed UAT for a phase I study.■ Through expedited data cleaning and query resolution, I was able to help lock a 500 subject database a week ahead of schedule.

■ Managed a 6 site, 30 subject Phase 2 Atopic Dermatitis study.○ Oversaw 3 sites directly as an assigned site monitor.○ Managed the CRAs assigned to the other 3 sites.○ Managed study vendors – photography, central laboratory, ECG reading, and 3 physician photo review panel.○ Created Monitoring Plan and ECG Completion Guidelines.■ Assisted in the management and oversight of project CRO for a 500 subject study including the following:○ Performed co-monitoring/assessment visits with CRO CRAs.○ Reviewed finalized trip reports from CRO.○ Reviewed reports from EDC to track patients.○ Presented at Investigator Meeting on the subject of GCP Compliance.■ Performed data cleaning on several Phase 2 studies.■ Completed UAT on eCRFs.■ Responsible for monitoring and oversight of study sites assigned to me on Vitiligo, Alopecia, and Common Warts studies.■ Trained new employees on the EDC system.■ Therapeutic areas: Atopic Dermatitis, Common Warts, Vitiligo, Alopecia

■ Contract employee through Planet Pharma■ Responsible for assisting in the management and oversight of project CRO included the following:○ Performed co-monitoring/assessment visits with CRO CRAs○ Reviewed finalized trip reports○ Reviewed and approved initial drug shipment packets○ Reviewed outstanding queries and safety report acknowledgements○ Reviewed protocol deviation log■ Helped drive the implementation for the company’s first Risk Based Monitoring study■ Assisted in listings review■ Reviewed and updated study documents as needed: ICFs, Monitoring Plan, Pharmacy Manual■ Working with a Pre-Audit Inspection Checklist, prepared a study for FDA inspection■ Helped to review and write patient narratives for inclusion in the Clinical Study Report■ Participated as a scribe in a mock FDA inspection○ Proposed several logistical changes that were incorporated into the audit plan.■ Therapeutic area: Parkinson’s Disease■ Created a training course for junior CRAs focusing on real-world experiences.

■ Contract employee through Aerotek.■ Primary responsibility was assisting in management and oversight of CRO ○ Tracked site visits and reviewed finalized trip reports. ○ Helped identify potential sites for the study. ○ Provided feedback on Study Visit Report templates, eCRF, eCRF completion guidelines, and User Acceptance Training. ○ Provided feedback and helped troubleshoot eCRF reports. ○ Reconciled Invoices and Site Grant Payments with services performed and study visits completed.■ Reviewed screening and enrollment, creating and updating trackers to help identify under-enrolling sites and project study progress.■ Provided oversight to centralized recruitment campaign, and created mailing lists for postcards■ Was responsible for updating study projections and timelines, then updating the study budget and projected payments to reflect the updated projections.■ Reviewed data to make study manager aware of trends, focusing on AE coding, concomitant medications, and subject dosing compliance.■ Drafted a Scope of Work for our Literature Search vendor.■ Reviewed study documents as needed: eCRFs, eCRF completion guidelines, User Acceptance Testing for EDC, Investigator Brochure update, IND Annual Report, Study Project Plan, Statistical Analysis Plan, Safety Plan, Proposed Tables, Figures and Listings, Study Newsletters, Informed Consent/Assent Forms.■ eTMF filing and creation of a TMF checklist■ Therapeutic areas included Acne and Rosacea.

■ Performed Pre-Study Visits, Initiation Visits, Interin Monitoring Visits, Close-out Visits■ Therapeutic areas include bird flu vaccine, pediatric milk allergy, pediatric antibiotics, psoriatic arthritis and unblinded on flu vaccine and pneumonia studies.■ Managed sites to ensure that enrollment goals were met.■ Served as the team expert on Medidata RAVE system for bird flu study.

■ Served as a Lead CRA on a Phase II pediatric vaccine trial. ○ Performed phone Site Qualification Visits, on-site Initiation Visits and Monitoring Visits.○ Was responsible for overseeing review process for the protocol, by including my feedback, and collecting the feedback of others.○ In collaboration with a CRO, managed contract CRAs assigned to the study.○ Created study documents including Regulatory Binder logs and diary cards and helped draft trip report templates and the clinical monitoring plan.■ Served as an Unblinded CRA on a Phase II MS trial. ○ Reviewed unblinded monitoring trip reports submitted by unblinded CRAs working at a CRO.○ Performed remote source document verification of drug accountability logs and temperature logs received from the sites.○ Worked with other unblinded team members to monitor the unblinded inbox and respond to drug dispensation issues.○ Shared on-call responsibility with 2 other unblinded staff members.○ Provided training on drug destruction process to unblinded CRAs.

■ Contract employee through About Consulting■ Primary responsibility was to serve as an in-house site manager for an asthma study that was currently enrolling subjects■ Worked with sites assigned to me to help them meet enrollment objectives and maintain quality objectives through the study.■ Worked to achieve cost objectives through tracking and verification of approved invoices against the study budget.■ Created the monthly study newsletter

■ Performed Pre-study Visits, Site Initiation Visits■ Therapeutic areas: Type 2 Diabetes Mellitus, non-Cystic Fibrosis Bronchiectasis, Psoriasis

■ Contract employee through Aerotek■ Performed Site Initiation Visits■ Therapeutic areas: Cancer (Sarcoma, Myeloma, Melanoma) and HIV, covering Phase I & II■ Responsibilities include creating study documents and updating study Manual of Procedures■ Using Velos system, programmed eCRFs and wrote corresponding CRF completion guidelines■ Manage sites and report on regulatory activity and approvals

■ Began work as a Clinical Research Assistant and was promoted up through Clinical Research Associate (entry level), Clinical Research Associate I, and Clinical Research Associate II.■ Performed Pre-study Visits, Site Initiation Visits, Site Monitoring Visits, and Close-out Visits.■ Therapeutic areas monitored: Vaccines (2 studies), Pediatric vaccines (1 study), Sleep disorders (1 study), Gastrointestinal (1 study). These studies included Phase II, Phase III, and Phase IIIb.■ Performed Investigational Product Accountability and reviewed site regulatory documents.■ Managed sites assigned to me.■ Reviewed and critiqued the protocol for the sleep disorder study.■ Trained new Clinical Research Associates on Site Initiation Visits and Site Monitoring Visits.■ Was specifically requested by sponsor for pediatric vaccine trial.■ Participated in a successful bid defense.■ Trained on ICH/GCP guidelines.

Main duties included testing urea for its pH and contents using the Bayer Clinitek 50. Also aided in operating the Dade-Behring Dimension RxL Max for blood testing, and performed data entry.